Apnea of PrematurityNCT05298748
The Effect of Womb Recordings on Maturation of Respiratory Control in Preterm Infants
A study testing Womb sound recordings in people with Apnea of Prematurity and Intermittent Hypoxemia, run by Case Western Reserve University at 1 site in United States.
Trial summary
The aim of this proposal is to characterize the acute effect of early postnatal sound exposure on neuronal maturation of the respiratory control regions of the brain in preterm infants. Read more about this study
- Who is it for?
- Ages 1 week to 5 weeks
- Conditions the study is for
- Apnea of Prematurity, Intermittent Hypoxemia, Bradycardia
- What is being tested?
- Womb sound recordings
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Sep 2022to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 week to 5 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- preterm infants 29-33 weeks gestational age at birth
- 34 weeks corrected age
- off respiratory support >1.5 lpm
Who cannot join
- on respiratory support >1.5 lpm
- congenital anomalies
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106-7061
Associate Chief Scientific Officer
Cynthia Bearer, MD
About this study
Official title: Womb Recordings and Respiratory Control Maturation in Neonates
The aim of this proposal is to characterize the acute effect of early postnatal sound exposure on neuronal maturation of the respiratory control regions of the brain in preterm infants.
Read the detailed description
The aim of this proposal is to characterize the acute effect of early postnatal sound exposure on neuronal maturation of the respiratory control regions of the brain in preterm infants. We hypothesize that exposure to appropriately designed womb-like sounds in the Neonatal Intensive Care Unit (NICU) will induce a more mature and stabilized cardiorespiratory pattern manifesting as a decrease in apnea, bradycardia, intermittent hypoxemia and mean heart rate.
This proposal lays the foundation for further development of actual womb and maternal voice recordings containing components that closely mimic the womb environment during 33-34 weeks of gestation, a proposed therapeutic window of brain development. These sound recordings will provide low risk interventions sorely needed to stabilize respiration, reduce intermittent hypoxemia and induce maturation of neuronal respiratory networks during this critical stage of development.
- Conditions
- Apnea of Prematurity, Intermittent Hypoxemia, Bradycardia
- Being tested
- Womb sound recordings
- Keywords
- apnea, intermittent hypoxemia, bradycardia, audio recording
- Medical subject headings
- Apnea, Bradycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Womb sound recordingsOther
Womb sounds will be chosen from commercially available (Amazon) womb recordings using a recording that most closely resembles the womb including maternal heart rate, fetal heartbeat, respiratory sounds, bowel "popping" sounds and frequency spectra as described by Parga, Daland 2018 et al.
| Study group | Role | What they receive |
|---|---|---|
| Ambient noise followed by Womb sound | Other | At 34 weeks corrected age, preterm infants (29-33 weeks gestational age at birth), who are off respiratory support >1.5 lpm, will be exposed to alternating 6-hour periods of a recording of ambient noise followed by commercially available womb sounds over a 24-hour period for a combined total of 12 hours of womb sounds and 12 hours of ambient noise. Receives: Other: Womb sound recordings |
| Womb sound recordings followed by ambient noise | Other | At 34 weeks corrected age, preterm infants (29-33 weeks gestational age at birth), who are off respiratory support >1.5 lpm, will be exposed to alternating 6-hour periods of a recording of commercially available womb sounds followed by ambient noise over a 24-hour period for a combined total of 12 hours of womb sounds and 12 hours of ambient noise. Receives: Other: Womb sound recordings |
What is being measured
The primary outcome is the main question the study is designed to answer.
cardiorespiratory events
Apnea (>20 seconds or shorter with intermittent hypoxemia <85% or bradycardia <80bpm)
Measured: During the 24 hour period of randomized blocks of womb sound recordings and ambient noise
intermittent hypoxemia
falls in oxygen saturation <85%
Measured: During the 24 hour period of randomized blocks of womb sound recordings and ambient noise
mean heart rate
mean heart rate
Measured: During the 24 hour period of randomized blocks of womb sound recordings and ambient noise
bradycardia
heart rate <80bpm
Measured: During the 24 hour period of randomized blocks of womb sound recordings and ambient noise
body motion
non-cardiac alterations in the oximeter plethysmograph waveform
Measured: During the 24 hour period of randomized blocks of womb sound recordings and ambient noise
respiratory pauses
Respiratory pauses of >5sec will be documented to increase the chance of capturing small alterations in respiratory stability.
Measured: During the 24 hour period of randomized blocks of womb sound recordings and ambient noise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2022
- Study start16 Sep 2022
- Primary completionOct 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (32)Papers the sponsor has linked to this study.
- Other trials for Apnea of PrematurityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- This is a single site, single visit study. The order of exposure, two 6 hour periods of ambient noise and two 6 hour periods of sound, will be randomized within each subject for a total of 24hrs of sound exposure.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Case Western Reserve University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cynthia Bearer, MD, Principal investigator, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05298748
- Sponsor's protocol ID
- STUDY20211638
- Status last verified
- Dec 2025
- First submitted
- 8 Mar 2022
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Noise: a hazard for the fetus and newborn. American Academy of Pediatrics. Committee on Environmental Health. Pediatrics. 1997 Oct;100(4):724-7. No abstract available.
PubMed 9836852Jobe AH, Bancalari E. An All-Inclusive Perspective on Bronchopulmonary Dysplasia. J Pediatr. 2021 Jul;234:257-259. doi: 10.1016/j.jpeds.2021.03.063. Epub 2021 Apr 1. No abstract available.
PubMed 33811871White RD, Smith JA, Shepley MM; Committee to Establish Recommended Standards for Newborn ICU Design. Recommended standards for newborn ICU design, eighth edition. J Perinatol. 2013 Apr;33 Suppl 1:S2-16. doi: 10.1038/jp.2013.10.
PubMed 23536026Almadhoob A, Ohlsson A. Sound reduction management in the neonatal intensive care unit for preterm or very low birth weight infants. Cochrane Database Syst Rev. 2015 Jan 30;1:CD010333. doi: 10.1002/14651858.CD010333.pub2.
PubMed 25633155Barateiro A, Brites D, Fernandes A. Oligodendrocyte Development and Myelination in Neurodevelopment: Molecular Mechanisms in Health and Disease. Curr Pharm Des. 2016;22(6):656-79. doi: 10.2174/1381612822666151204000636.
PubMed 26635271Benzaquen S, Gagnon R, Hunse C, Foreman J. The intrauterine sound environment of the human fetus during labor. Am J Obstet Gynecol. 1990 Aug;163(2):484-90. doi: 10.1016/0002-9378(90)91180-k.
PubMed 2386134Brockmann PE, Wiechers C, Pantalitschka T, Diebold J, Vagedes J, Poets CF. Under-recognition of alarms in a neonatal intensive care unit. Arch Dis Child Fetal Neonatal Ed. 2013 Nov;98(6):F524-7. doi: 10.1136/archdischild-2012-303369. Epub 2013 May 28.
PubMed 23716498Coleman RJ, Beharry KD, Brock RS, Abad-Santos P, Abad-Santos M, Modanlou HD. Effects of brief, clustered versus dispersed hypoxic episodes on systemic and ocular growth factors in a rat model of oxygen-induced retinopathy. Pediatr Res. 2008 Jul;64(1):50-5. doi: 10.1203/PDR.0b013e31817307ac.
PubMed 18344903Corrigan MJ, Keeler JR, Miller HD, Ben Khallouq BA, Fowler SB. Music therapy and retinopathy of prematurity screening: using recorded maternal singing and heartbeat for post exam recovery. J Perinatol. 2020 Dec;40(12):1780-1788. doi: 10.1038/s41372-020-0719-9. Epub 2020 Jul 17.
PubMed 32681063Decker MJ, Rye DB. Neonatal intermittent hypoxia impairs dopamine signaling and executive functioning. Sleep Breath. 2002 Dec;6(4):205-10. doi: 10.1007/s11325-002-0205-y.
PubMed 12524574Di Fiore JM, Bloom JN, Orge F, Schutt A, Schluchter M, Cheruvu VK, Walsh M, Finer N, Martin RJ. A higher incidence of intermittent hypoxemic episodes is associated with severe retinopathy of prematurity. J Pediatr. 2010 Jul;157(1):69-73. doi: 10.1016/j.jpeds.2010.01.046. Epub 2010 Mar 20.
PubMed 20304417Di Fiore JM, Kaffashi F, Loparo K, Sattar A, Schluchter M, Foglyano R, Martin RJ, Wilson CG. The relationship between patterns of intermittent hypoxia and retinopathy of prematurity in preterm infants. Pediatr Res. 2012 Dec;72(6):606-12. doi: 10.1038/pr.2012.132. Epub 2012 Oct 4.
PubMed 23037873Doheny L, Hurwitz S, Insoft R, Ringer S, Lahav A. Exposure to biological maternal sounds improves cardiorespiratory regulation in extremely preterm infants. J Matern Fetal Neonatal Med. 2012 Sep;25(9):1591-4. doi: 10.3109/14767058.2011.648237. Epub 2012 Feb 2.
PubMed 22185623Emery L, Hamm EL, Hague K, Chorna OD, Moore-Clingenpeel M, Maitre NL. A randomised controlled trial of protocolised music therapy demonstrates developmental milestone acquisition in hospitalised infants. Acta Paediatr. 2019 May;108(5):828-834. doi: 10.1111/apa.14628. Epub 2018 Dec 7.
PubMed 30375661Jiang NM, Cowan M, Moonah SN, Petri WA Jr. The Impact of Systemic Inflammation on Neurodevelopment. Trends Mol Med. 2018 Sep;24(9):794-804. doi: 10.1016/j.molmed.2018.06.008. Epub 2018 Jul 11.
PubMed 30006148
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Womb Recordings and Respiratory Control Maturation in Neonates
- ClinicalTrials.gov ID
- NCT05298748
- Acronym / sponsor ID
- STUDY20211638
- Conditions
- Apnea of Prematurity, Intermittent Hypoxemia, Bradycardia
- Keywords
- apnea, intermittent hypoxemia, bradycardia, audio recording
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Case Western Reserve UniversityUniversity, hospital or other
- Study start
- 16 Sep 2022 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 28 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this proposal is to characterize the acute effect of early postnatal sound exposure on neuronal maturation of the respiratory control regions of the brain in preterm infants.
Detailed description
The aim of this proposal is to characterize the acute effect of early postnatal sound exposure on neuronal maturation of the respiratory control regions of the brain in preterm infants. We hypothesize that exposure to appropriately designed womb-like sounds in the Neonatal Intensive Care Unit (NICU) will induce a more mature and stabilized cardiorespiratory pattern manifesting as a decrease in apnea, bradycardia, intermittent hypoxemia and mean heart rate.
This proposal lays the foundation for further development of actual womb and maternal voice recordings containing components that closely mimic the womb environment during 33-34 weeks of gestation, a proposed therapeutic window of brain development. These sound recordings will provide low risk interventions sorely needed to stabilize respiration, reduce intermittent hypoxemia and induce maturation of neuronal respiratory networks during this critical stage of development.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a single site, single visit study. The order of exposure, two 6 hour periods of ambient noise and two 6 hour periods of sound, will be randomized within each subject for a total of 24hrs of sound exposure.
| Arm | Type | Receives |
|---|---|---|
| Ambient noise followed by Womb sound | Other | Other: Womb sound recordingsAt 34 weeks corrected age, preterm infants (29-33 weeks gestational age at birth), who are off respiratory support >1.5 lpm, will be exposed to alternating 6-hour periods of a recording of ambient noise followed by commercially available womb sounds over a 24-hour period for a combined total of 12 hours of womb sounds and 12 hours of ambient noise. |
| Womb sound recordings followed by ambient noise | Other | Other: Womb sound recordingsAt 34 weeks corrected age, preterm infants (29-33 weeks gestational age at birth), who are off respiratory support >1.5 lpm, will be exposed to alternating 6-hour periods of a recording of commercially available womb sounds followed by ambient noise over a 24-hour period for a combined total of 12 hours of womb sounds and 12 hours of ambient noise. |
Who may qualify
- Ages
- 1 week to 5 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- preterm infants 29-33 weeks gestational age at birth
- 34 weeks corrected age
- off respiratory support >1.5 lpm
Key exclusion criteria (2 listed)
- on respiratory support >1.5 lpm
- congenital anomalies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Womb sound recordingsWomb sounds will be chosen from commercially available (Amazon) womb recordings using a recording that most closely resembles the womb including maternal heart rate, fetal heartbeat, respiratory sounds, bowel "popping" sounds and frequency spectra as described by Parga, Daland 2018 et al. | Other | Ambient noise followed by Womb sound, Womb sound recordings followed by ambient noise |
Primary outcome
cardiorespiratory events
Time frame: During the 24 hour period of randomized blocks of womb sound recordings and ambient noise
Apnea (>20 seconds or shorter with intermittent hypoxemia <85% or bradycardia <80bpm)
intermittent hypoxemia
Time frame: During the 24 hour period of randomized blocks of womb sound recordings and ambient noise
falls in oxygen saturation <85%
mean heart rate
Time frame: During the 24 hour period of randomized blocks of womb sound recordings and ambient noise
mean heart rate
bradycardia
Time frame: During the 24 hour period of randomized blocks of womb sound recordings and ambient noise
heart rate <80bpm
body motion
Time frame: During the 24 hour period of randomized blocks of womb sound recordings and ambient noise
non-cardiac alterations in the oximeter plethysmograph waveform
respiratory pauses
Time frame: During the 24 hour period of randomized blocks of womb sound recordings and ambient noise
Respiratory pauses of >5sec will be documented to increase the chance of capturing small alterations in respiratory stability.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
- Background: PubMed 9836852Noise: a hazard for the fetus and newborn. American Academy of Pediatrics. Committee on Environmental Health. Pediatrics. 1997 Oct;100(4):724-7. No abstract available.
- Background: PubMed 33811871Jobe AH, Bancalari E. An All-Inclusive Perspective on Bronchopulmonary Dysplasia. J Pediatr. 2021 Jul;234:257-259. doi: 10.1016/j.jpeds.2021.03.063. Epub 2021 Apr 1. No abstract available.
- Background: PubMed 23536026White RD, Smith JA, Shepley MM; Committee to Establish Recommended Standards for Newborn ICU Design. Recommended standards for newborn ICU design, eighth edition. J Perinatol. 2013 Apr;33 Suppl 1:S2-16. doi: 10.1038/jp.2013.10.
- Results publication: PubMed 25633155Almadhoob A, Ohlsson A. Sound reduction management in the neonatal intensive care unit for preterm or very low birth weight infants. Cochrane Database Syst Rev. 2015 Jan 30;1:CD010333. doi: 10.1002/14651858.CD010333.pub2.
- Results publication: PubMed 26635271Barateiro A, Brites D, Fernandes A. Oligodendrocyte Development and Myelination in Neurodevelopment: Molecular Mechanisms in Health and Disease. Curr Pharm Des. 2016;22(6):656-79. doi: 10.2174/1381612822666151204000636.
- Results publication: PubMed 2386134Benzaquen S, Gagnon R, Hunse C, Foreman J. The intrauterine sound environment of the human fetus during labor. Am J Obstet Gynecol. 1990 Aug;163(2):484-90. doi: 10.1016/0002-9378(90)91180-k.
- Results publication: PubMed 23716498Brockmann PE, Wiechers C, Pantalitschka T, Diebold J, Vagedes J, Poets CF. Under-recognition of alarms in a neonatal intensive care unit. Arch Dis Child Fetal Neonatal Ed. 2013 Nov;98(6):F524-7. doi: 10.1136/archdischild-2012-303369. Epub 2013 May 28.
- Results publication: PubMed 18344903Coleman RJ, Beharry KD, Brock RS, Abad-Santos P, Abad-Santos M, Modanlou HD. Effects of brief, clustered versus dispersed hypoxic episodes on systemic and ocular growth factors in a rat model of oxygen-induced retinopathy. Pediatr Res. 2008 Jul;64(1):50-5. doi: 10.1203/PDR.0b013e31817307ac.
- Results publication: PubMed 32681063Corrigan MJ, Keeler JR, Miller HD, Ben Khallouq BA, Fowler SB. Music therapy and retinopathy of prematurity screening: using recorded maternal singing and heartbeat for post exam recovery. J Perinatol. 2020 Dec;40(12):1780-1788. doi: 10.1038/s41372-020-0719-9. Epub 2020 Jul 17.
- Results publication: PubMed 12524574Decker MJ, Rye DB. Neonatal intermittent hypoxia impairs dopamine signaling and executive functioning. Sleep Breath. 2002 Dec;6(4):205-10. doi: 10.1007/s11325-002-0205-y.
- Results publication: PubMed 20304417Di Fiore JM, Bloom JN, Orge F, Schutt A, Schluchter M, Cheruvu VK, Walsh M, Finer N, Martin RJ. A higher incidence of intermittent hypoxemic episodes is associated with severe retinopathy of prematurity. J Pediatr. 2010 Jul;157(1):69-73. doi: 10.1016/j.jpeds.2010.01.046. Epub 2010 Mar 20.
- Results publication: PubMed 23037873Di Fiore JM, Kaffashi F, Loparo K, Sattar A, Schluchter M, Foglyano R, Martin RJ, Wilson CG. The relationship between patterns of intermittent hypoxia and retinopathy of prematurity in preterm infants. Pediatr Res. 2012 Dec;72(6):606-12. doi: 10.1038/pr.2012.132. Epub 2012 Oct 4.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cynthia Bearer, MD principal investigator
University Hospitals Cleveland Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Womb sound recordings in people with Apnea of Prematurity and Intermittent Hypoxemia, run by Case Western Reserve University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cynthia Bearer, MD (216 844-3387, Cynthia.Bearer@UHhospitals.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cardiorespiratory events (time frame: During the 24 hour period of randomized blocks of womb sound recordings and ambient noise). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05298748, which also lists 32 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2025.